Method and apparatus for guidance and application of high intensity focused ultrasound for control of bleeding due to severed limbs

ABSTRACT

An ultrasonic diagnostic and therapy system is described for stopping the bleeding of severely damaged bloodvessels or vessels severed in a limb amputation. A cuff ( 30 ) is attached to the stump of the severed limb which contains a diagnostic transducer array and a HIFU transducer ( 42, 44 ). The diagnostic transducer surveys the tissue of the severed limb, searching for a Doppler flow signal. When a Doppler flow signal is detected, the range to and coordinates of the sample volume where the flow was detected are determined, as well as the flow velocity. This information is supplied to a HIFU therapy transducer controller, which controls the HIFU transducer to transmit focused ultrasound to the sample volume of the flow locus, the center of the lumen of a blood vessel. The focused ultrasound heats and coagulates blood in the severed vessel to stem the bleeding.

This invention relates to medical diagnostic and therapeutic ultrasoundsystems and, in particular, to methods and apparatus for controllingbleeding from severed blood vessels with high intensity focusedultrasound.

Battlefield trauma injuries involving proximal amputation of limbs arecommon in warfare. Severed limbs can also occur in automobile andindustrial accidents and from other causes. The major cause of loss oflife in these cases is rapid exsanguination from the major arteries ofthe arm or leg, the brachial and femoral arteries, respectively. Thesewounds are very difficult to deal with in an emergency setting, as thecrudely severed ends of the arteries do not spasm closed, and retractinto the limb, making access to clamp them difficult or impossible. Amethod and apparatus for use at the scene of the injury by minimallytrained emergency medical technicians is desired.

Application of high intensity focused ultrasound (HIFU) in the low MHzfrequency range has been shown to reduce and eliminate bleeding inpunctured and slashed arteries through the effects of heating the arterywalls and the blood itself, albeit in smaller arteries and with slowerflow than the larger arterial vessels mentioned above. Accordingly it isdesirable to have apparatus and methods which can be used to treatbleeding from any peripheral vessel quickly and effectively in anemergency situation.

In accordance with the principles of the present invention therapyapparatus is described which uses a complete or partial cuff applied tothe stump of an affected limb, including a flow sensing transducer and ahigh intensity ultrasound transducer. The two transducers are in a knownrelationship to each other so that the data of blood flow located ortracked by the flow sensing transducer can be used to guide theapplication of high intensity ultrasound to the blood flow. Supportingelectronics for the transducers as well as a simple display mechanismcan be located on the cuff or in an instrument attached to the cuff. Thedisplay allows rapid alignment by the operator of the cuff in proximityto the detected flow region (the target vessel). A flow processorconnected to the flow sensing transducer provides automaticdetermination of the distance between the cuff and the target vessel.The high intensity ultrasound transducer may be an annular or lineararray, and transmits one or more high intensity focused ultrasound(HIFU) spots, or a HIFU line beam, focused along the blood vessel at thedepth determined by the flow processor to be appropriate.

In an example described below, multiple Doppler and HIFU phased arraysare used to automatically acquire locational and functional data of thehigh flow vessel for internal use by the system, and to transmit atailored HIFU beam to heat the vessel along a segment of its length.Delivering HIFU energy along a length of a blood vessel can besignificant to successful coagulation of blood in the severed vessel.

Acoustic coupling of the cuff transducers to the limb can be provided byan impedance matched pad or fluid-filled enclosure. The cuff can be usedwith coupling gel on the skin for rapid achievement of good ultrasoundcoupling over the extended area required.

In the drawings:

FIG. 1 illustrates in block diagram form an ultrasonic diagnostic andtherapeutic system constructed in accordance with the principles of thepresent invention for treatment of severed blood vessels.

FIG. 2 illustrates one example of a transducer cuff constructed inaccordance with the principles of the present invention.

FIG. 3 illustrates a second example of a transducer cuff constructed inaccordance with the principles of the present invention.

FIG. 4 is a detailed block diagram of the signal processing and controlsystem of an ultrasonic diagnostic and therapeutic apparatus constructedin accordance with the principles of the present invention.

FIG. 5 illustrates one method of using the transducer cuff of FIG. 2 toheat the blood of a located blood vessel.

FIG. 6 illustrates a second method of using the transducer cuff of FIG.2 to heat the blood of a located blood vessel.

FIG. 7 illustrates a first method of using the transducer cuff of FIG. 3to heat the blood of a located blood vessel.

FIG. 8 illustrates a second method of using the transducer cuff of FIG.3 to heat the blood of a located blood vessel.

FIG. 9 illustrates a third method of using the transducer cuff of FIG. 3to heat the blood of a located blood vessel.

FIG. 10 illustrates a third example of a transducer cuff constructed inaccordance with the principles of the present invention.

FIG. 11 illustrates an example of a system of the present inventionwhich has a row of visual indicators to guide the user in placement ofthe transducer cuff in proximity to a blood vessel.

Referring first to FIG. 1, an ultrasonic diagnostic and therapeuticsystem constructed in accordance with the principles of the presentinvention for treatment of severed blood vessels is shown in blockdiagram form. A transducer cuff 10 which contacts the severed limb inthe vicinity of a bleeding blood vessel contains a diagnostic transducer12 and a therapy transducer 14. The diagnostic transducer locates theblood vessel, preferably by Doppler detection of the flow of blood. Thediagnostic transducer is coupled to the diagnostic section 20 of thesystem. The diagnostic transducer is controlled by a flow transceiver 22of the diagnostic section which actuates the transducer and receivesecho signals from the blood vessel. The echo signal information iscoupled to a flow processor 24 of the diagnostic section whichdetermines the location of the blood vessel and, in examples describedbelow, also the rate (velocity) of the blood flow. This blood flowinformation is coupled to a therapy processor 132 in the therapeuticsection 130 of the system. The therapy processor 132 utilizes theinformation to control the delivery of ultrasonic therapy to the bloodflow through control of a therapy transmitter 134 of the therapeuticsection. High intensity ultrasound is focused on the blood of the bloodvessel through use of the locational and flow information provided bythe diagnostic transducer. Treatment proceeds until the blood in thevessel has been sufficiently coagulated to stem the flow of blood. Adisplay indicator 16 which is shown located on the transducer cuff 10,but may alternatively be located on an instrument containing thediagnostic or therapeutic sections, provides visual guidance to the userin the placement of the transducer cuff in proximity to a flowing bloodvessel and can also indicate when treatment is proceeding and hasconcluded. Alternatively or in addition to a visual indicator, audibleinstructions may be produced by the system to guide the user.

In use, the transducer cuff 10 is placed on or wrapped around the end ofthe severed limb. When a wrap-around cuff is used the cuff is inflatedor tightened to be in good acoustic and stationary position on the skinof the patient and above a severed blood vessel. The diagnostictransducer locates the blood vessel, preferably by Doppler sensing ofthe highest flow velocity below the transducers. The location of theblood vessel is computed, as is the Doppler velocity of blood flow. Thisinformation is supplied to the therapy processor which controls thetherapy transmitter to transmit high intensity ultrasound focused at thedepth and lateral location of the blood vessel. The diagnostictransducer monitors the vessel during treatment. This monitoring caninclude continually tracking the location of the blood vessel to keepthe therapy transducer focused on the appropriate area of the vessel,and monitoring the flow to determine when coagulation has occurred andthe flow of blood has stopped and the treatment is finished. Thediagnostic information can also be, but does not have to be, displayedif desired. In one example described below a length of the blood vesselis heated during treatment by delivering a line of heat align the bloodvessel to coagulate the blood. In another example a spot of highintensity ultrasound is focused on a bolus of blood and moved with theblood flow to continuously heat the same bolus of blood as it movesthrough the blood vessel below the therapy transducer. These techniquesare useful for overcoming the continual dissipation of heat in thevessel due to the high rate of blood flow carrying the heat through andout of the severed vessel. The application of the HIFU energy over anextended region of the artery allows the blood to be heated to asufficient temperature to promote coagulation without exceeding theallowable thermal dose in the intervening tissue.

Numerous examples of a system of the present invention are illustratedand described below. In one example a partial cuff with a cylindricalarray is used as the HIFU source so the X-Y location of a line focusedultrasound beam is set by the user moving the cuff on the skin surface.The user is guided by a simple user interface (e.g., a speedometerindicator or an array of colored LEDs) which give an indication of theskin location where the highest flow is detected. Duplicate diagnosticdetector arrays at both ends and/or alongside the HIFU array enablealignment of the cuff in close proximity to the vessel being treated.The focal depth of the HIFU beam is set automatically by the transmittercircuitry driving the cylindrical therapy array, based on the range ofthe detected maximum Doppler signals at the multiple detector systems.This example uses a single large cylindrical array to deliver sufficientenergy to provide coagulation over an extended region along the vessel.

In another example a transducer cuff of multiple phased arrays isapplied to the limb so the whole volume is interrogated by means ofelectronic beam steering. The cuff is guided and positioned so that oneor more therapeutic HIFU arrays are located parallel to the bloodvessel. The therapeutic beam location for coagulation is determined bythe high flow rate indicative of a severed vessel which is higher thanthe flow rate should be when the blood flow rate is moderated by theresistance of a capillary bed. There are also Doppler signal anomaliesin the vicinity of the leak, and in the blood pool around where the leakhas been flowing. In this case, delivering sufficient power to allowcoagulation is achieved by the use of multiple transducers fortherapeutic power generation.

FIG. 2 is one example of a transducer cuff 30 of the present invention.The cuff 30, shown here in cross-section, is an inflatable bladder-likesleeve similar to that used for blood pressure measurements. The cuffcan be made in different sizes (diameters) for arm or leg use. In a cuffsuitable for arm use the transducers may extend completely around thecuff or only a portion of the arc of the cuff such as an arc oftransducers subtending 90° to 135° of arc. The illustrated example ofFIG. 2 uses transducers subtending an arc of 135°. A suitable arc forthe leg is approximately 9 cm by 9 cm. For the arm a suitable arc isapproximately 6 cm by 6 cm. The cuff 30 has an inner surface 32 whichcontacts the limb of the patient and an outer surface 34. The spacebetween these surfaces can be inflated with an inflation pump 36.Inflation of the cuff accomplishes three objectives: it presses thetransducers on the inside of the cuff into good acoustic contact withthe limb of the patient; it secures the transducers in a stationaryposition with respect to the underlying blood vessels; and it provides atourniquet force around the limb to help stem the flow of blood. Thetourniquet function can slow the flow of blood so that more time isavailable to diagnose and treat a bolus of blood within range of thetransducers. A lower flow rate can also be treated effectively with alower dose of acoustic energy. The cuff 30 is coupled to a therapy anddiagnostic delivery system 100 which controls the diagnostic and therapytransducers. The transducers are attached to the inner surface of thecuff. Two cylindrically curved array therapy HIFU transducers 42 and 44are located at the inner surface. Interspaced at the ends and betweenthe HIFU transducers in this example are three two-dimensional phasedarray transducers 52, 54, and 56. All of the transducers are mounted soas to be well acoustically coupled to the limb of the patient inside thecuff. One way to provide acoustic coupling is to locate the transducersin a fluid-filled compartment. In this example a dotted line 38represents a urethane membrane which encloses the transducers in afluid-filled compartment between the membrane 38 and the inner surface32 of the cuff 30. Another way to provide acoustic coupling is with anacoustic coupling pad located between the emitting surfaces of thetransducers and the skin of the patient. In this example acousticcoupling pads 46, 48, 51, 53, and 55 are shown on the emitting surfacesof the transducers 42, 44, 52, 54, and 56. Separate pads or onecontinuous pad may be used. The acoustic coupling pads may be made of asolid cis-polybutadiene standoff material or a gel material such asKitecko standoff pads.

The two dimensional phased array transducers 52, 54 and 56 are made ofdiced piezoelectric material. The HIFU transducer elements may be formedof solid piezoelectric material or a composite of piezoelectric ceramicand epoxy, which enables the curved HIFU arrays to be bent into thedesired arcuate shape. The two dimensions of the array allow Dopplerinterrogation of a volume below the arrays so that the arrays cansystematically search for a locus of high flow rate inside the limb. TheHIFU transducers 42 and 44 are diced in their longitudinal dimension(indicated by the arrow L) so that the therapeutic beams can be focusedat selected depths of focus below the skin surface where the bloodvessels are located. The HIFU transducers 42, 44 can also be diced inthe elevational direction (into the plane of the drawing as indicated atE) to enable steering and focusing of the therapeutic beams at selectedbeam angles where the vessels are located, and to track the flow of abolus of blood through a vessel. The HIFU transducers are preferablyquasi-air-backed to reduce significant heating in the backing. Athermally conductive matching layer and a support frame coated with alow impedance intermediate layer may be used for good heat transfer tothe standoff pad and mechanical support for the HIFU transducers. Thetransducers are preferably backed with attached flip-chipmicrobeamformers to control operation of the transducers and to preventsignificant energy loss between the driving circuitry and the transducerelements by driving the transducer elements directly. Suitablemicrobeamformers and microbeamforming techniques in general aredescribed in U.S. Pat. No. 6,375,617 (Fraser), U.S. Pat. No. 5,997,479(Savord) and U.S. Pat. No. 6,126,602 (Savord).

The therapy transducers 42, 44 are operated in a lower MHz range of 2.5to 4 MHz, for instance. Even lower frequencies of 1.0 to 1.5 MHz may bepreferred for very deep arterial vessels. The diagnostic transducers 52,54, 56 are operated in this range or higher depending upon the desiredrange of operating depths, with lower frequencies being preferred fordeeper leg depths and higher frequencies for shallower arm depths. Thediagnostic transducers will generally be operated with a full aperture,with the therapy transducers operable with a full aperture orsubapertures of groups of elements of the arrays. The drive pulses forthe HIFU transducers may be pulse width modulated for improvedefficiency.

FIG. 3 illustrates in a perspective view a second example of atransducer cuff 60 of the present invention. In this example the outersurface 34 of the cuff has been removed to visualize the transducerarrays on the inner surface 32 of the cuff. The HIFU arrays 62 and 64 inthis example are aligned with their longitudinal axes (as indicated byarrow L) parallel to the center axis A of the cuff. This orientation ofthe therapy arrays will tend to align them with blood vessels extendingto the severed end of a limb, particularly the larger femoral andbrachial arteries of the leg and arm. The 2D Doppler arrays 71, 72, 73,74, and 75 are located at the ends of the therapy arrays, between thetherapy arrays, or both as illustrated in the example of FIG. 3. Thetherapy arrays 62 and 64 are diced in both the longitudinal dimension Land in the elevational dimension E (indicated by arrow E) for full rangeof therapeutic beam focusing and steering. The transducer arrays arefabricated and acoustically coupled as described previously. Optionally,the cuff 60 may include one or more force or pressure sensors 82, 84 and86 which are attached to the inner surface 32 of the cuff. These sensorsmay be piezoelectric elements or strain gauges which sense the force orpressure of the inner surface of the cuff against the limb. When thesignals produced by these sensors fall below a predetermined limit, theyproduce an indication that the cuff has not been attached securelyenough to the limb or is loosening, which will cause disruption of theacoustic coupling between the transducer arrays and the patient. Thecondition may be resolved by re-inflating the cuff 60.

FIG. 4 is another example in accordance with the principles of thepresent invention in which the diagnostic and therapeutic sections of atherapy diagnosis and delivery system are shown in greater detail. Atherapy controller 160 controls both aspects of the apparatus. Thetherapy controller 160 is coupled to an image drive 120 to command theimage drive to produce drive signals for the diagnostic transducerarrays 12 of the cuff 10. The term “image” is not meant here to suggestthat an ultrasound image is formed, as imaging is not necessary in animplementation of the present invention, Rather, the term here impliesthat the ultrasonic energy transmitted by the diagnostic arrays is inthe power range used for diagnostic imaging and below the therapeuticenergy range. The drive signals are provided to a transmit/receivecontroller 122 which in turn controls microbeamformers 124 to cause thediagnostic arrays 12 to methodically scan the volume below them, lookingfor a high intensity or velocity Doppler return. The echo signalsreceived by the transmit/receive controller 122 are coupled to a Dopplerprocessor which Doppler processes the echo signals from the transmittedand received beams as by FFT processing. When a severed blood vessel iswithin the range of one of the diagnostic arrays a strong or highvelocity Doppler signal will be received from a sample volume located ata particular point in the limb inside a blood vessel. This indicationmay be communicated to the therapy controller 160 by the Dopplerprocessor 24 as a “flow detected” signal, in which event the therapycontroller will cause the “Flow” LED 164 on a display 162 to light. Fromthe angle of the Doppler beam direction and the range (depth) from whichthe Doppler signal is returned, the x,y,z coordinates of the center ofthe blood vessel may be determined. The number of adjacent samplevolumes from which the strong or high velocity Doppler signal isreturned, or a computation of the volume flow, indicates the size of theblood vessel. This information, size, velocity (V), and location (x,y,z)are coupled to a therapy planner 150. Other echo signals may provideother information about the tissue between the blood vessel and thearray such as the presence of foreign material such as shrapnel orglass, as well as tissue beyond the vessel which may be sensitive totreatment such as bone or nerves. The therapy planner uses thisinformation to develop control signals for the therapy and signals thetherapy controller 160 that a flow source has been located and thattherapy can begin.

The therapy controller responds to this information by lighting the“Therapy” LED 164 on the display 162. The therapy controller commands atherapy drive 142 to commence operation and therapy begins. The therapydrive 142 provides drive signals to therapy beamformers 144. The drivesignals cause therapeutic beams to be transmitted by a therapy array 14at a power level determined by the information provided by the therapyplanner 150. The power level will generally be a function of the size ofthe blood vessel (larger vessels requiring more power) and the flow rate(higher flow rates requiring more power). The therapy planner 150provides the x,y,z location of the blood vessel center (where flow isgreatest) which is used by the therapy drive 142 and therapy beamformers144 to steer the therapy beams in the correct direction and focus thebeams at the center of the blood vessel. A time signal t provides a timevariation providing the length of time that the therapeutic beams are tobe focused at the indicated location in the blood vessel.

Periodically the therapy controller 160 interrupts the therapy tocommand the diagnostic transducer array to resample the therapy area tomake sure that the center of the blood vessel has not moved from itspreviously determined location. The velocity and direction of the bloodflow indicate the location where a bolus of blood, found at an earlierpoint in time, is expected to be at a later point in time. The areaaround the is expected location is scanned by the diagnostic transducerand the nearest sample volume of greatest velocity and/or Doppler signalintensity is identified as the location where the previously heatedbolus of blood may be found at the later (now current) point in time.The therapy planner 150 responds by appropriately adjusting the controlparameters for the therapy drive 142 and beamformers 144. In this mannera bolus of blood may be initially heated as it comes within range of thearrays, and may be tracked and continue to be heated as it flows to thesevered end of the blood vessel. This bolus of blood will be at a highertemperature, and thus more likely to precipitate coagulation, than wouldbe a bolus of blood passing through a fixed focal point of the therapyarray. In this manner the dissipation of heat by the flow of blood isaddressed. Others who have studied the physiological phenomena involvedin this process suggest that heating causes the vessel to shrink,slowing the flow, and the pool of blood around the severed end iscoagulated to form a seal.

FIG. 5 illustrates how this procedure may occur through use of thetransducer cuff of FIG. 2. Inside the inflated cuff 30 is a severed limbof the patient with a bone such as the femur 200 shown at the center ofthe limb. A blood vessel such as the femoral artery 202 is located inthe volume of tissue surrounding the femur 200. The diagnostictransducer 54 has located the blood flow in the femoral artery 202 inthe beam direction of the dashed line extending from the transducerarray 54 to the femoral artery. The range (depth) and directionalinformation of this beam is used to direct the aperture or a subapertureof the therapy array 42 to focus high intensity ultrasonic energy at thefemoral artery as indicated by the solid lines extending form thetherapy array 42 to the femoral artery 202. Since the therapeutic energyoriginates from an extended length of the array at the skin surface, theenergy density is not sufficient to cause damage to the tissue betweenthe therapy array 42 and the femoral artery 202. It is only when thisenergy comes into focus inside the blood vessel that the energy densitybecome high enough to cause heating and the intended coagulation ofblood in the severed vessel 202.

FIG. 6 illustrates how the transducer arrays of the transducer cuff 30track and heat a bolus of blood as it moves through a section of theartery 202 to its severed distal end 204. The blood flow of the vessel202 is initially detected as it comes into range at a focal point F1.The segmentation of the curved 2D array 42 enables the therapeutic beamto be steered to and focused initially at the focal point F1 asindicated by dashed lines 2,2′. The velocity information indicates thespeed at which the bolus of blood is moving through the blood vessel 202and it is tracked and heated as it moves through the vessel. As a latertime the bolus is at focal point F2, which is identified by thediagnostic arrays 52,54 as indicated by the dashed lines 5,5′ extendingfrom the diagnostic arrays. The diagnostically determined range andlocation information of the focal point F2 is used to cause the therapyarray 42 to be focused at focal point F2 at this time as indicated bydashed lines 4,4′. Eventually the same bolus of blood is at the extremeof the transducer range, blood vessel, or both as indicated by focalpoint F3. The therapeutic beams are steered and focused at point F3 atthis time as indicated by dashed lines 6,6′. Thus, the same bolus ofblood is tracked and repeatedly or continuously heated as it progressesalong a length segment of blood vessel 202. In this example it is seenthat the diagnostic arrays are oriented toward each other so that theirbeams intersect in the region of the blood vessel 202. In thisorientation the diagnostic arrays 52,54 may be operated in thepulse-echo mode in which each array transmit and then receives echoesfrom its own transmissions, or in dedicated transmit and receive modesin which ultrasound is transmitted by one of the diagnostic arrays andthe resultant echoes received by the other diagnostic array for Dopplerprocessing. Continuous wave techniques may thus be employed in thisconfiguration.

FIG. 7 illustrates one technique for using the cuff 60 of FIG. 3 inaccordance with the principles of the present invention. In theillustrated orientation the cuff position is adjusted until the “Flow”indicator indicates that a blood vessel is located beneath thediagnostic arrays 71,72. The therapy array 62 is then aligned with theaxis of the blood vessel as indicated by the center line C. When thetherapy array 62 is a two dimensional array segmented in the elevationdimension E, beams can be focused from along the therapy array 62 to thecenter C of the blood vessel 202. The exact center of the blood vesselalong the length beneath the therapy array 62 can be determined by usinga diagnostic array (not shown) on one or both sides of the therapyarray, or by canting the diagnostic arrays 71,72 toward the area beneaththe therapy array. For instance, each diagnostic array 71,72 could scanin from its end of the therapy array to the center of the array. Thecenter C of the blood vessel 202 beneath the therapy array 62 can befound in this manner and heated along the entire length of the bloodvessel beneath the array. This is a second approach to addressing heatdissipation by the flow of blood through the severed vessel 202.

FIG. 8 is similar to FIG. 7 except that in this example subgroups ofelements of the therapy transducer 62 are focused in the azimuthal(longitudinal) direction rather than the elevational direction as donein FIG. 7. Different consecutive subgroups of therapy transducerelements along the array are focused at the center line C of the bloodvessel 202, from the subgroup at one end of the array focusing beamsbetween dashed lines 4-4′ to the subgroup at the other end of the arrayfocusing beams between dashed lines 2-2′.

FIG. 9 illustrates use of the transducer cuff of FIG. 3 to track andrepeatedly heat a bolus of blood as it flows to the distal end 204 ofthe severed blood vessel 202. A bolus of blood is initially heated whenit is located by the diagnostic array 72 at the proximal end of thetherapy array 62. As the bolus flows to the distal end of the severedvessel 202 an activated subgroup 63 of therapy elements moves along thearray 62 in the tracking direction T at the velocity of the flowingblood, thereby repeatedly heating the same bolus of blood as ittraverses the blood vessel segment beneath the therapy array 62. Theblood flow of the vessel is tracked through the length of the vessel bythe diagnostic arrays 71,72 located at the longitudinal ends of thetherapy array 62, and/or by diagnostic arrays located on one or bothsides of the therapy array 62 (not shown).

FIG. 10 illustrates a partial cuff 300 constructed in accordance withthe principles of the present invention. The partial cuff 300, shown incross-section in FIG. 10, has an inner surface 304 to which thetransducer arrays 42-56 are connected and an outer surface 302completing the enclosure of the transducer arrays. The space between thesurfaces can be fluid-filled for acoustic coupling of the transducers,and/or acoustic coupling pads can be provided at the inner surface 304as described previously. The partial array is attached to the limb ofthe patient by straps 306, 308 extending from the inner surface 304 ateach end of the partial cuff. The straps can be secured together with abuckle or clip or other fastening means. In the example of FIG. 9 thestraps. 306, 308 include complementary Velcro® surfaces 310 and 312,enabling the straps to be quickly and securely fastened tightly aroundthe limb of a patient, then quickly opened and removed.

FIG. 11 illustrates an example of a diagnostic and therapy deliverysystem of the present invention with a display to help guide the user insuccessful location of the transducer cuff. In this example the cuff 10includes at least one diagnostic array and at least one therapy array 14as discussed in conjunction with FIG. 1. In this example the cuff isintended to be attached with the therapy array 14 parallel to anddirectly over a blood vessel of the injured limb. The parallelorientation is readily accomplished by virtue of the orientation of thetherapy array 14 parallel to the axis of the transducer cuff. Alignmentof the therapy array directly over a blood vessel is made possible by aline of indicators 16, in this example a row of LEDs. After the cuff isinitially placed in acoustic contact with the limb, the diagnostictransducer 12 methodically scans the volume inside the cuff, searchingfor a strong and/or high velocity Doppler signal. When such blood flowis located, the lateral angle of the Doppler beam to the flow indicatesthe direction in which the cuff must be moved to locate the therapyarray 14 directly over the blood vessel. For instance, if the bloodvessel is to the left of the aligned diagnostic and therapy transducers,the Doppler beam will be angled to the left when directed at a samplevolume in the vessel. Simple geometry then computes the distance whichthe cuff must be moved to bring the arrays directly over the bloodvessel, at which point the Doppler beam will extend orthogonal to theemitting surface of the transducer when directed at the sample volume.An exact distance is not needed in this case, just the information thatthe cuff must be moved to the left, that is, the left/right direction ofbeam inclination. In the example of FIG. 11 the line 16 of LEDs extendslaterally to the left and right of the therapy array 14. If the lateraldistance of the leftward blood vessel is greater than the lateraldistance from the center of the line of LEDs, indicated by the darkenedLED, to the leftmost LED 18, the LED 18 is illuminated. The user nowknows the cuff must be moved to the left. As the cuff is moved and theDoppler beam angle approaches orthogonality to the diagnostic array, thecenter of the therapy array will approach the location of the bloodvessel and as it gets closer, more inward LEDs are lighted. Finally whenthe blood vessel is centered beneath the therapy array the center LED isilluminated. The change in the illuminated LED will thus quickly guidethe user in correctly positioning the arrays over a blood vessel formost effective and efficient heating and coagulation.

It will be appreciated that the LED display 16 can be augmented with, oreven replaced by, audible prompts from the system instructing the userto “move the cuff to the right” or “move the cuff to the left” and“stop” when the cuff is correctly positioned over a blood vessel.

Variations of the systems and techniques described above are within thescope of the present invention. For instance a heated bolus of blood maybe tracked by receiving the strong harmonics emanating from the heatedbolus with a diagnostic transducer, as described in U.S. Pat. No.5,984,881 (Ishibashi et al.). Blood flow tracking may be performed byoperating the therapy transducer in a receive mode. Other variationswill readily occur to those skilled in the art.

What is claimed is:
 1. An ultrasonic diagnostic and therapy system for reducing blood flow of a peripheral blood vessel by ultrasonic heating comprising: a transducer cuff configured for attachment to a limb, including at least one diagnostic transducer and at least one therapy transducer; a flow transceiver coupled to the diagnostic transducer for controlling a transmission of ultrasound by the diagnostic transducer and receiving echo signals from blood flow in response to the transmitted ultrasound; a flow processor coupled to the flow transceiver and responsive to the echo signals for identifying a location of blood flow; a therapy processor, responsive to the identification of a location of blood flow, for producing therapy control signals for the identified location; and a therapy transmitter, coupled to the therapy transducer, and operable to cause the therapy transducer to deliver high intensity focused ultrasound to the identified location of blood flow, wherein the therapy transmitter is operable to deliver high intensity focused ultrasound at intensity levels which produce heating at the identified location of blood flow, the therapy processor includes a therapy controller which acts to cause the therapy transducer to produce heat in a blood vessel until flow velocity in the vessel determined by the flow processor declines to an acceptable level, and the therapy controller acts to suspend the delivery of high intensity focused ultrasound by the therapy transducer while the diagnostic transducer acquires flow echo information.
 2. The ultrasonic diagnostic and therapy system of claim 1, wherein the flow processor comprises a Doppler processor responsive to a receipt of Doppler echo signals for identifying a location of blood motion.
 3. The ultrasonic diagnostic and therapy system of claim 2, wherein the Doppler processor produces estimates of flow velocity.
 4. The ultrasonic diagnostic and therapy system of claim 1, wherein the flow transceiver controls the transmission of ultrasound by the diagnostic transducer to be within diagnostic imaging power limits.
 5. The ultrasonic diagnostic and therapy system of claim 1, wherein the flow processor operates to identify a location of blood flow in three dimensional space.
 6. The ultrasonic diagnostic and therapy system of claim 1, wherein the therapy processor is responsive to signals from the flow processor which indicate vessel size, flow velocity in the vessel, and flow location in the vessel.
 7. The ultrasonic diagnostic and therapy system of claim 1, wherein the therapy processor produces control signals which control the power delivered by the therapy transducer, the time of actuation of the therapy transducer, and the focal point of delivered high intensity focused ultrasound.
 8. The ultrasonic diagnostic and therapy system of claim 1, wherein the transducer cuff exhibits a controllable pressure which acts to control the contact of the transducers with the limb.
 9. The ultrasonic diagnostic and therapy system of claim 8, wherein the transducer cuff exhibits a controllable high pressure which acts to restrict blood flow through blood vessels of the limb.
 10. The ultrasonic diagnostic and therapy system of claim 8, wherein the transducer cuff exhibits a controllable high pressure which acts to increase the acoustic coupling between the transducers and the limb.
 11. The ultrasonic diagnostic and therapy system of claim 8, wherein the transducer cuff exhibits a controllable high pressure which acts to stabilize the position of the transducers with respect to blood vessels in the limb.
 12. The ultrasonic diagnostic and therapy system of claim 1, further comprising a display responsive to the flow processor which is actuated to indicate that a location of blood flow has been identified.
 13. The ultrasonic diagnostic and therapy system of claim 12, wherein the display comprises one or more light emitting devices.
 14. The ultrasonic diagnostic and therapy system of claim 13, wherein the display comprises a two or three dimensional image display.
 15. The ultrasonic diagnostic and therapy system of claim 1, further comprising an audible emitter responsive to the flow processor which is actuated to indicate that a location of blood flow has been identified.
 16. The ultrasonic diagnostic and therapy system of claim 15, wherein the audible emitter is further responsive to the flow processor for guiding the placement of the transducer cuff. 